A to Z of MS
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A to Z of MS Fampridine (Fampyra)
Fampyra (Europe), Ampyra (US)
Fampridine is drug that has been shown to improve walking speed for some people with multiple sclerosis.
A phase III study involving 301 people with both relapsing and progressive MS who were treated for 14 weeks was reported in The Lancet in 2009. This showed a greater proportion of people taking fampridine had a consistent improvement in walking speed, compared to people taking placebo (34.8 percent v 8.3 percent) as measured by the Timed 25-Foot Walk test. This improvement was maintained for the duration of the study.
Fampridine was granted a conditional licence by the European Medicines Agency (EMA), the European Union's regulator, in July 2011. The licence requires the manufacturer, Biogen Idec, to carry out further research about the benefits and long-term safety of fampridine. In particular, the study will provide information on benefits beyond the effect on walking speed.
In April 2013, the NHS Commissioning Board, which funds specialist services inthe NHS in England, issued a policy statement in which it said "Fampridine is not considered to be a cost-effective use of NHS resources."
Fampridine was licensed by the Federal Drug Administration (FDA), the American regulatory body, in January 2010. The product name in the USA is Ampyra.
In 2003, the Cochrane Review, an independent organisation that reviews research, published a report covering six trials of fampridine as a treatment for various symptoms. Although there was no apparent effect on cognitive symptoms, 54% of participants reported some degree of improved muscle function, 9% reported improvements in walking and 9% also showed improvement on the EDSS scale, a standard measure of neurological disability.
How fampridine works
Fampridine is a formulation of 4-Aminopyridine - a potassium channel blocker, which works by blocking some of the chemical processes in nerves and seems to improve the transmission of messages along damaged nerves.
How is fampridine given?
Fampridine is taken orally as tablets.
Side effects and contraindications
Common side effects experienced included falls, back pain, dizziness, insomnia, fatigue, nausea and balance disorders.
Fampridine should not be used by people with a history of seizures or who have moderate to severe kidney problems.
In July 2012 the FDA (the US drug regulator) issued a Safety Announcement about the risk of seizures in the weeks following the first dose of fampridine. Most reported instances had been in people with no previous history of seizures. The FDA also recommended that kidney function should be checked before treatment starts and then at least annually and that people missing a dose should not take extra doses.
Committee for Medicinal Products for Human Use (CHMP).
Positive opinion on the marketing authorisation for Fampyra (fampridine).
Issued 19 May 2011.
read online (pdf 52kb)
Clinical commissioning policy statement: Fampridine for multiple sclerosis.
NHSCB/D04/PS/d. April 2013.
read online (pdf 202kb)
Goodman AD, et al.
Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial.
Korenke AR, et al.
Sustained-release fampridine for symptomatic treatment of multiple sclerosis.
Annals of Pharmacotherapy 2008;42(10):1458-1465.
Solari A, et al.
Aminopyridines for symptomatic treatment in multiple sclerosis.
Cochrane Database Systematic Review 2003;(2).
FDA Drug Safety Communication
Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine)
23 July 2012
Patient Information Leaflets
- Fampyra (EMC website)